Free-Cell Area Impact on Stroke Prevention in Asymptomatic Patients Undergoing Carotid Artery Stenting: The "Carotid Artery sTenting And CeLl-area Impact on Stroke and Major Adverse events" (CATACLISMA) Multicenter Registry.

PURPOSE: The study investigated the association between cell-stent area and cerebrovascular events incidence in asymptomatic patients undergoing carotid artery stenting (CAS). MATERIALS AND METHODS: This is an observational, retrospective, multicenter, cohort study. Between 2012 and 2022, all patients undergoing primary CAS for severe asymptomatic carotid artery stenosis were evaluated. Three groups were defined on the basis of the cell area (open cell, OC; closed cell, CC; double layer, DL). Periprocedural primary outcomes were 30-day stroke, mortality, myocardial infarction (MI), and major adverse event (MAE, stroke/mortality composite outcome) rates. Follow-up primary outcomes included overall survival, stroke-free survival (SFS), freedom from ipsilateral stroke (FFiS), and freedom from stroke-related mortality (FF-SRM). Data were analyzed at short-term (1 year) and mid-term (2.5 years) period. RESULTS: A total of 1096 CAS were considered (787 men, 71.8%, median age = 74 years). Technical success was achieved in 99.5% procedures. Periprocedural 30-day stroke rate was 1.5% (OC: 1.1%, CC: 2.3%, DL: 1%, p=0.27), mortality was 0.7% (OC: 1.1%, CC: 0.3%, DL: 0.5%, p=0.35), and no MI was recorded. The MAE rate was 2.1% (OC: 2%, CC: 2.6%, DL: 1.5%, p=0.66). Median follow-up was 46 months. At 1 and 2.5 years, estimated overall survival was 96.1% and 91% (p=0.41), SFS was 99.1% and 98.2% (p=0.007, CC stroke rates 2.9% and 4.2% at timepoints), FFiS was 99.4% and 99% (p=0.014, CC FFiS rates 1.7% and 2.6% at timepoints) and FF-SRM was 99.5% and 99% (p=0.28). During follow-up, no stroke events occurred in DL group. CC design showed higher rates of any (4.2%) and ipsilateral stroke (2.6%) within 2.5 years. CONCLUSION: In asymptomatic patients undergoing CAS, the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. The DL stents may offer the best available performances in terms of mid-term stroke prevention. CLINICAL IMPACT: The study analyzed the contemporary results of carotid artery stenting (CAS) focusing on the impact of cell-stent area on peri- and post-operative cerebrovascular events in a multicenter real-world experience. In asymptomatic patients undergoing CAS the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. DL stents may offer the best available performances in terms of mid-term stroke prevention.

Preliminary experience of the isolate left subclavian artery in-situ fenestration during "zone 2" thoracic endovascular aortic repair.

OBJECTIVES: To evaluate the results of isolate left subclavian artery (LSA) in-situ fenestration (ISF) during "zone 2" thoracic endovascular aortic repair (TEVAR) using a new adjustable needle puncturing device system. METHODS: It is a multicentre, retrospective, physician-initiated cohort study of patients treated from July 28th 2021 to April 3rd 2024. Inclusion criteria were isolate LSA revascularization for elective or urgent/emergent "zone 2" TEVAR. The primary outcome was technical success and freedom from ISF TEVAR-related reintervention or endoleak. RESULTS: We treated 50 patients: 28 (56.0%) atherosclerotic thoracic aneurysms, 12 (24.0%) type B aortic dissection, and 10 (20.0%) penetrating aortic ulcers. Elective intervention was carried out in 46 (92.0%) cases. ISF was successful in all cases, with a procedural primary technical success in 47 (94.0%) cases. Median time of intervention was 184 min (IQR, 135-220) with a median fenestration time of 20 min (IQR, 13-35). Operative mortality did not occur. We observed 1 case of spinal cord ischaemia, and 2 cases of bilateral posterior non-disabling stroke. Mortality at 30 days occurred in 1 (2.0%) patient (not aorta-related). The median follow-up median follow-up of 4 months (IQR, 1-12.25). Bridging stent graft patency was 100% with no ISF-related endoleak. In-situ fenestration-related reintervention was never required. CONCLUSIONS: ISF TEVAR using the Ankura™-II device with the self-centering adjustable needle system showed high technical success, promising stability, and stable aortic-related outcomes. Owing to these results, it represents a safe and effective alternative for standard "zone 2" TEVAR.

An analysis of early and long-term gender-related outcomes after thoracic endovascular aortic repair.

OBJECTIVES: To evaluate gender-related outcomes during endovascular treatment of thoracic and thoraco-abdominal aortic diseases (TEVAR). METHODS: Multicentre, retrospective, observational cohort study. All TEVARs between January 2005 and April 2023 were identified. Primary outcomes were 30-day mortality, and cumulative survival. Secondary outcomes were vascular access complications, and freedom from TEVAR-related reintervention. Interventions performed in male patients were matched to females on the basis of a one-to-one coarsened exact matching. RESULTS: We identified 151 males who were matched with 151 females. Mortality at 30-day was not statistically different between females and males (11.2% vs 11.2%, P = 1.0). At binary logistic regression analysis, duration of intervention (P = 0.001), and emergency TEVAR (P = 0.001) were associated with mortality at 30 days. Gender did not impact access vessel complication rate [n = 6 (4.0%) vs n = 5 (3.3%), P = 1.0]. The median of follow-up was 46 (IQR, 7-84) months with no difference between males and females [median, 50 (11-95) vs 37.5 (3.5-71.2); P = 0.153]. Estimated survival was not statistically different between females and males (Log-rank χ2 = 0.6, P = 0.442; 95% CI: 110.7-207.3). At Cox's regression analysis, gender did not impact overall survival (HR: 0.8, 95% CI: 0.6-1.3, P = 0.450). Estimated freedom from TEVAR-related reinterventions was not statistically different between females and males (Log-rank χ2 = 0.4, P = 0.837; 95% CI: 187.8-219.3). CONCLUSIONS: Female gender itself was not associated with worse 30-day mortality and late survival than males with similar access vessel complication as well as TEVAR-related reintervention rate.

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

Outcome analysis of the surgical team in open surgical repair of intact abdominal aortic aneurysm surgery.

OBJECTIVES: To analyze how the experience of the surgical team went to impact the outcomes after open surgical repair (OSR) of intact abdominal aortic aneurysms (AAAs). METHODS: This is a single-center, observational cohort study with retrospective analysis of all OR for intact AAA performed between 1 January 2010 and 31 December 2022. The primary outcome was survival at 30 days and in follow-up, and a composite outcome of mortality and major complication. The secondary outcome was freedom from aorta-related reintervention. All outcomes were stratified according to the experience of the operating team (surgeons and anesthesiology). RESULTS: We analyzed 103 (7.2%) patients: 97 (94.2%) males and 6 (5.8%) females. The mean age was 76 ± 8 years (range, 55-93). The best possible team composition was present in 52 (50.5%) interventions. The follow-up index was 0.82 ± 0.18 (range, 0.6-1.0). Mean follow-up duration was 59 ± 43 months (range, 0-158). We observed no differences between teams in major complications (best, 17.3% vs mixed, 21.6%; OR: 0.4, P = 0.622), 30 days mortality (best, 0% vs mixed, 5.9%; OR: 7.6, P = 0.118) and composite outcome (best, 11.5% vs mixed, 17.6%; OR: 0.8, P = 0.416). Cox regression analysis identified the best possible team as a protective factor against the need for reintervention (hazard ratio: 0.2; 95% confidence interval: 0.06-0.88, P = 0.032). CONCLUSIONS: In our experience, OR of AAA yielded satisfactory results in terms of safety and efficacy independently of the team's experience. A more experienced team may protect against aorta-related reintervention.

Clinical cases referring to the 2023 EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ.

Clinical cases referring to the EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ aim to assist physicians in selecting the best management strategies for individual patients with a given condition. These expert opinions consider the impact on patient outcomes as well as the risk-benefit ratio of different diagnostic or therapeutic methods. These cases serve as a vital tool to aid physicians in making decisions in their daily practice. However, in essence, although these recommendations serve as a valuable resource to guide clinical practice, their application should be tailored to the needs of the individual patient. Each patient's case is unique, presenting its own set of variables and circumstances. This editorial is a tool designed to support, but not supersede, the decision-making process of physicians, based on their knowledge, expertise and understanding of their patients' individual situations. Furthermore, these clinical cases are based on the EACTS/STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ but should not be interpreted as legally binding documents. The legal responsibilities of healthcare professionals remain firmly grounded in applicable laws and regulations, and the guidelines and the clinical cases presented in this document do not alter these obligations.

Long-Term Survival and Reintervention Following Thoracic Endovascular Aortic Repair in Blunt Traumatic Thoracic Aortic Injury: A Systematic Review and Meta-Analysis.

BACKGROUND: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma. Different management strategies are available with varying clinical outcomes. However, thoracic endovascular aortic repair (TEVAR) has become the first-line option for most BTAI patients, mainly owing to its minimally invasive nature, yielding improved immediate results. This meta-analysis aims to investigate mortality, long-term survival, and reintervention following TEVAR in BTAI. MATERIAL AND METHODS: A systematic review conducted a comprehensive literature search on multiple electronic databases using strict search terms. Twenty-seven studies met the set inclusion/exclusion criteria. A proportional meta-analysis of extracted data was conducted using the Comprehensive Meta-Analysis Software, v.4. RESULTS: 1498 BTAI patients who underwent TEVAR were included. Using the SVS grading system, 2.6% of the population had Grade 1 injuries, 13.6% Grade 2, 62.2% Grade 3, 19.6% Grade 4, and 1.9% unspecific. All-cause mortality did not exceed 20% in all studies except one outlier with a 37% mortality rate. Using the random effects model, the pooled estimate of overall mortality was 12% (95% confidence interval [CI], 5.35-8.55%; I2 = 70.6%). This was 91% (95% CI, 88.6-93.2; I2 = 30.2%) at 6 months, 90.1% (95% CI, 86.7-92.3; I2 = 53.6%) at 1 year, 89.2% (95% CI, 85.2-91.8; I2 = 62.3%) at 2 years, and 88.1% (95% CI, 83.3-90.9; I2 = 69.6%) at 5 years. Moreover, the pooled estimate of reintervention was 6.4% (95% CI, 0.1-0.49%; I2 = 81.7%). CONCLUSIONS: Despite the high morbidity and mortality associated with BTAI, TEVAR has proven to be a safe and effective management strategy with favorable long-term survival and minimal need for reintervention. Nevertheless, diagnosis of BTAI requires a high index of suspicion with appropriate grading and prompt transfer to trauma centers with appropriate TEVAR facilities.

Expert-Based Narrative Review on Contemporary Use of an Off-The-Shelf Multibranched Endograft for Endovascular Treatment of Thoracoabdominal Aortic Aneurysms: Device Design, Anatomical Suitability, Technical Tips, Perioperative Care, Clinical Applications, and Real-World Experience.

Advanced endovascular techniques, such as fenestrated stent grafts, are nowadays available that permit minimally invasive treatment of complex abdominal aortic aneurysms. However, thoracoabdominal aortic aneurysm patients have anatomic limitations to fenestrated stent-grafts given a large lumen, that is, the gap between the endograft and the inner aortic wall. This has led to the development of branched endovascular aneurysm repair as the ideal option for such patients. The Zenith t-Branch multibranched endograft (Cook Medical, Bloomington, IN), which has been commercially available in Europe to treat thoracoabdominal aortic aneurysm since June 2012, represents a feasible off-the-shelf alternative for treatment of such pathologies, especially in the urgent setting, for patients who cannot wait the time required for manufacturing and delivery of custom-made endografts. The device's anatomical suitability should be considered, especially for female patients with smaller iliofemoral vessels. Several tips may help deal with particularly complex scenarios (such as, for instance, in case of narrow inner aortic lumens or when treating patients with failure of prior endovascular aneurysm repair), and a broad array of techniques and devices must be available to ensure technical and clinical success. Despite promising early outcomes, concerns remain particularly regarding the risk for spinal cord ischemia and further assessment of long-term durability is needed, including the rate of target vessel instability and need for secondary interventions. As the published evidence mainly comes from retrospective registries, it is likely that reported outcomes may suffer from an intrinsic bias as most procedures reported to date have been carried out at high-volume aortic centers. Nonetheless, with the never-ceasing adoption of new and refined techniques, outcomes are expected to ameliorate.

Current expert-based opinions on endovascular treatment of blunt thoracic aortic injury: A state-of-the-art narrative review on indications, techniques, results, and challenges.

INTRODUCTION: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma which warrants prompt recognition with expedited management. Clinical manifestations of BTAI may not be straightforward to detect and may be misdiagnosed. Therefore, diagnosis of BTAI requires a high index of suspicion based on the mechanism of injury along with urgent transfer to centers with appropriate expertise and facilities. METHODS: We provide an expert-based narrative review on endovascular treatment of BTAI highlighting indications, techniques, results, and challenges. RESULTS: Multiple imaging modalities can be used including computed tomography angiography, transesophageal echocardiography, magnetic resonance imaging, and intravascular ultrasound. Whilst conservative pharmacological management can be a safe option in low-grade BTAI, thoracic endovascular aortic repair has become the gold-standard strategy in most cases, replacing open surgical repair. Nevertheless, it is important to account for patient demographics particularly age, severity of injury, choice of endograft including its type and size, and endovascular technique including landing zone and left subclavian artery revascularization. CONCLUSIONS: Overall, TEVAR in BTAI has been shown to be an efficacious strategy with favorable early outcomes. In contrast, less is known on the long-term clinical outcomes of TEVAR in BTAI. Hence, despite the optimal early technical and clinical success rates, concerns remain about the need for long-term surveillance. The exact timing of follow-up and the integration of different modalities that can also investigate potential downstream cardiovascular effects remain hot topics for future research. Finally, industry should focus on developing more compliant endografts to improve the stiffness mismatch between the endograft and the aorta to optimize results.

Proposal of a classification of cannulation damage in vascular access grafts based on clinical, ultrasound, and microscopic observations.

INTRODUCTION: Arteriovenous grafts (AVGs) serve as an alternative to native arteriovenous fistulas (AVFs) in the context of hemodialysis patient life planning. AVGs are more susceptible to developing outflow stenosis (due to intimal hyperplasia), thrombosis, and infections. However, an often overlooked contributor to AVG failure is cannulation damage. The objective of this paper is to assess the impact of cannulations on AVGs. We aim to establish a classification of AVG damage by comparing clinical data and ultrasound images with microscopic morphological findings obtained from explanted grafts. MATERIALS AND METHODS: This study is conducted at a single center. We included all patients who underwent AVG creation between 2011 and 2019. Comprehensive data on clinical history, follow-up, and complications were collected and reviewed. Duplex ultrasound (DUS) characteristics were documented, and all grafts explanted during the analysis period underwent optical microscopy evaluation. Finally, clinical data, along with DUS and microscopic findings, were integrated to derive a damage classification. RESULTS: During the study period, 247 patients underwent 334 early cannulation AVGs. The median follow-up duration was 714 days (IQR 392, 1195). One hundred eleven (33%) grafts were explanted. Clinical data and DUS findings were utilized to formulate a four-grade classification system indicating increasing damage. CONCLUSION: Cannulation damage alone does not solely account for AVG failure. It results from a biological host-mediated process that promotes the growth of intimal hyperplasia at the cannulation sites. This process is not clinically significant within the initial 2 years after AVG creation.

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery.

BACKGROUND: Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass. METHODS: Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model. RESULTS: Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years. CONCLUSIONS: In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.

Comparative outcomes of aortobifemoral bypass with or without previous endovascular kissing stenting of the aortoiliac bifurcation.

OBJECTIVE: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D). METHODS: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. RESULTS: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups. CONCLUSIONS: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

Endovascular aneurysm repair under local anesthesia through bilateral percutaneous femoral access is a safe strategy to improve early outcomes and reduce hospital stay.

BACKGROUND: To estimate the impact of anesthetic conduct, alone and in combination with the type of femoral access, on early results after endovascular aneurysm repair (EVAR). METHODS: A retrospective multicenter analysis on patients undergoing elective standard EVAR at four academic centers was performed. Patients undergoing the procedure through either local or general anesthesia were compared. Comparative subanalyses of the two groups were performed for the type of femoral access to evaluate further impact on outcomes. RESULTS: Five hundred twenty-four patients underwent elective standard EVAR, of which 207 (39.5%) under general anesthesia and 317 (60.5%) under local anesthesia. Patients who underwent general anesthesia had higher 30-day mortality rates (3.4% vs. 0.3%, P=0.005), as well as slightly worse 30-day major systemic complication rates (8.2% vs. 5.4%, P=0.195). There were no differences in terms of reinterventions (2.1% vs. 2.5%, P=0.768) and aneurysm-related mortality (0% vs. 0.4%, P=0.422) at one year. Total intervention times were significantly longer in the general anesthesia group (126 vs. 89 minutes, P=0.001), as well as the total length of hospital stay (7.6 vs. 5.3 days, P=0.007). At subanalyses, the combination of local anesthesia with bilateral percutaneous femoral access further improved 30-day outcomes and determined an additional reduction in total intervention times and ICU stays. CONCLUSIONS: EVAR performed under local anesthesia has a significantly better impact on early results when compared to general anesthesia. Combining percutaneous bilateral femoral access to local anesthesia reduced procedural times, ICU stays and consequently improved early results.

Results of the Italian Collaborators for Evar Registry on Acute Kidney Injury After Elective Endovascular Aortic Repair of Infrarenal Abdominal Aortic Aneurysm.

OBJECTIVES: To analyze the incidence and predictive factors of postoperative acute kidney injury (AKI) after elective standard endovascular aortic repair (EVAR) in a large recent, multicenter cohort. MATERIALS AND METHODS: This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study. Between January 2018 and March 2021, only patients treated with elective standard EVAR for infrarenal non-infected abdominal aortic aneurysm were analyzed. Patients already on hemodialysis (HD) were excluded. AKI was defined as an increase in serum creatinine (sCr) ≥0.3 mg/dL within 48 hours or an increase in sCr to ≥1.5 times baseline known or presumed to have occurred within 7 days, or a urine volume of <0.5 mL/kg/h for 6 hours. Primary outcomes of interest were AKI incidence at 30 days and freedom from HD at 1-year follow-up. Secondary outcomes were freedom from severe postoperative complication, and freedom from aorta-related mortality (ARM) at 1 year. RESULTS: The final cohort analyzed 526 (29.8%). There were 489 (93%) males and 37 (7%) females: the median age was 76 years (interquartile range [IQR], 71-81). Chronic kidney disease (CKD) was present in 86 (16.3%) patients. Early mortality was observed in 8 (1.5%) patients, none was aorta-related. Complication rate was 17.1% (n=89). AKI was observed in 17 (3.2%). Renal replacement therapy was needed in 4 (0.8%). HD was transitory in 2 cases and definitive in 1. Binary logistic regression analysis identified CKD (odds ratio [OR]: 4.68, 95% confidence interval [CI]: 2.10-10.45, p<0.001), and the presence of renal artery stenosis (OR: 3.80, 95% CI: 1.35-10.66, p=0.011) to be associated with an increased risk of postoperative AKI. Estimated freedom from ARM was 94.9% at 1 year. Estimated freedom from HD rate at 1 year was 94%: This was significantly different between patients with preoperative CKD and those who did not have preoperative CKD (log-rank, p=0.042). CONCLUSION: AKI after elective standard EVAR still occurs but with an acceptably low incidence rate. Preoperative CKD is the most important predictor for postoperative AKI, which was not associated with the need for HD at 1-year follow-up but with a higher propensity of mortality. CLINICAL IMPACT: This "real world" experience confirm that EVAR performed with standard contrats agent protocol remains safe for acute kidney injury development. Therefore, only patients presenting with preoperative borderline or ascertained chronic kidney disease will take the most advantage from the use of carbon dioxide contrast.

Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study.

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). METHODS: A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two-hundred-forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available.

Guidelines on the diagnosis, treatment and management of visceral and renal arteries aneurysms: a joint assessment by the Italian Societies of Vascular and Endovascular Surgery (SICVE) and Medical and Interventional Radiology (SIRM).

The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended.

Cardiac risk after elective endovascular repair for infrarenal abdominal aortic aneurysm: Results from the Italian Collaborators for EVAR multicenter registry.

OBJECTIVE: Major adverse cardiac events (MACEs) were common complications after endovascular aortic repair (EVAR) causing significant postoperative morbidity and mortality. The aim of the study was to evaluate the cardiac risk after elective EVAR for uncomplicated noninfected infrarenal abdominal aortic aneurysm in a large multicenter cohort. METHODS: This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study conducted by four academic tertiary referral hospitals from January 2018 to March 2021. Baseline, perioperative, and postoperative information of elective EVARs was evaluated. The primary outcome was the incidence of MACEs after EVAR, which was defined as acute coronary syndrome, non-ST-elevation myocardial infarction, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, and revascularization as well as cardiovascular death. Secondary outcomes were 1-year overall survival (all-cause mortality) and freedom from aorta-related mortality. Comparative analysis was conducted between MACE and overall population, and univariate and multivariate logistic regression analyses were used to analyze factors associated with the risk of the MACE occurrence and early 1-year mortality. RESULTS: The study has enrolled 497 patients (35 females, 7%) with a mean age of 75.3 ± 7.8 years. The MACE rate was 6.4% (32/497, events/patients), and the majority of the events were recorded in the postoperative period (24/32, 75%; overall 24/497, 4.8%). One-year survival from all-cause mortality was 94% (95% confidence interval [CI]: 91-96), and the MACE population showed a significantly lower survival estimation rate (Overall - MACEs, 95.8% [95% CI: 93-97] - 67.9% [95% CI: 47-82], log-rank 41.950, P = .0001). Freedom from aorta-related mortality was 99.3% (95% CI: 98-100). The perioperative need for red blood cell transfusions was strongly related to the MACE occurrence (odds ratio: 2.67, 95% CI: 1.52-4.68, P = .001) and 1-year mortality (hazard ratio: 2.14, 95% CI: 1.48-3.09, P = .0001). CONCLUSIONS: MACEs represent a common complication in the postoperative and early period after elective EVAR. Blood loss requiring red blood cell transfusions is associated with increased postoperative MACEs and early mortality, suggesting that all the efforts should be carried out to reduce the bleeding during and after elective interventions.

Implanted blood vessel external support device for the treatment of distal hypoperfusion ischemic syndrome in arteriovenous fistulas and high-frame-rate Vector Flow quality assessment.

INTRODUCTION: Distal hypoperfusion ischemic syndrome (DHIS) is a complication occurring after arteriovenous fistula (AVF) creation. Different surgical alternatives haves been proposed in case of severe DHIS. Aim of the present paper is to present a new technique for DHIS treatment. MATERIAL AND METHODS: Between the 1st of January 2021 and the 31st December 2021 all the patients referred to our center for DHIS grade 2-4 were treated with a new surgical technique. It consists of AVF remodeling using an external nitinol support (VasQ®) to reduce the risk of outflow vein enlargement and DHIS recurrence. To better appreciate the hemodynamic effects of the surgery, a new ultrasound technique called high-frame-rate Vector Flow (HiFR-VF) was used. RESULTS: Seven patients (M:F 1:3; mean age 43 ± 12 years, range 29-65) were included in this study. Central line was never necessary, and technical success was 100% at 12 months. The comparison with historical data demonstrated lower recurrence of symptoms in comparison to simple artery-to-vein redo (p 0.50). The HiFR-VF showed flow with limited turbulent characteristics at the anastomosis site. DISCUSSION AND CONCLUSION: The new technique proposed demonstrated to be safe and effective for treatment of DHIS, preventing symptoms recurrence. Ultrasound examination and HiFR-VF can be considered a valuable method to evaluate complex flows at the levels of vascular anastomosis.